ICROSS 40 MHZ CORONARY IMAGING CATHETER
Report
- Report Number
- 2939204-2011-00129
- Event Type
- Injury
- Date Received
- March 29, 2011
- Date of Event
- March 4, 2011
- Report Date
- March 8, 2011
- Manufacturer
- BOSTON SCIENTIFIC - FREMONT
- Product Code
- DQO
- PMA / PMN Number
- K063312
- Removal / Correction Number
- 90657289-FA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THE LOT AND NO ISSUE OR DISCREPANCIES WERE FOUND. A SIMILAR COMPLAINT WAS FOUND IN THIS LOT; HOWEVER, REVIEW OF THE INFORMATION FOUND THE CAUSE WAS NOT RELATED TO LABELING OR MANUFACTURING. THE CATHETER WAS RETURNED IN TWO PIECES. FIRST PIECE, THE DISTAL TIP END, MEASURED 2.3CM LONG AND THE REST OF THE CATHETER MEASURED 169.1CM LONG. VISUAL INSPECTION OF THE RETURNED CATHETER OBSERVED FLUID INSIDE OF THE TELESCOPE AND DISTAL TIP ASSEMBLY. NO FLUID WAS FOUND INSIDE THE HUB AND NO KINK WAS OBSERVED IN THE SHEATH ASSEMBLY. KINKS WERE OBSERVED AT THE BROKEN DISTAL TIP ASSEMBLY LIKELY RESULTING FROM OPERATIONAL CONTEXT. THE FLUSHPORT HOUSING ASSEMBLY WAS BROKEN OFF AND THE CHECK VALVE WAS MISSING LIKELY RESULTING FROM HANDLING DAMAGE. THESE APPEAR TO BE UNRELATED TO THE TIP BREAK. DURING IMAGE CHARACTERIZATION TESTING A GOOD IMAGE APPEARED IN THE SYSTEM AND THE PRODUCT PERFORMED WITHIN SPECIFICATION. A SAMPLE OF THE DEVICE WAS SENT TO AN OUTSIDE VENDOR FOR OXIDATION ANALYSIS. BASED ON THE INFORMATION GATHERED, HIGH LEVELS OF OXIDATION AT THE SURFACE AND AT THE SURFACE OF THE IMAGING WINDOW WERE NOTED. THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) CONTAINS THESE WARNINGS: NEVER ADVANCE OR WITHDRAW THE IMAGING CATHETER WITHOUT FLUOROSCOPIC VISUALIZATION BECAUSE IT MAY CAUSE VESSEL INJURY OR PATIENT COMPLICATIONS. DO NOT ADVANCE THE CATHETER IF RESISTANCE IS ENCOUNTERED. THE CATHETER SHOULD NEVER BE FORCIBLY INSERTED INTO LUMENS NARROWER THAN THE CATHETER BODY OR FORCED THROUGH A TIGHT STENOSIS. A CATHETER THAT IS FORCIBLY ADVANCED MAY CAUSE CATHETER DAMAGE RESULTING IN VESSEL INJURY OR PATIENT COMPLICATIONS. IF RESISTANCE IS MET UPON WITHDRAWAL OF THE CATHETER, VERIFY RESISTANCE USING FLUOROSCOPY, THEN REMOVE THE ENTIRE SYSTEM SIMULTANEOUSLY. A CATHETER THAT IS FORCIBLY REMOVED MAY CAUSE VESSEL INJURY OR PATIENT COMPLICATIONS. WHEN ADVANCING THE CATHETER THROUGH A STENTED VESSEL, CATHETERS THAT DO NOT COMPLETELY ENCAPSULATE THE GUIDEWIRE MAY ENGAGE THE STENT BETWEEN THE JUNCTION OF THE CATHETER AND GUIDEWIRE, RESULTING IN ENTRAPMENT OF CATHETER/GUIDEWIRE, CATHETER TIP SEPARATION, AND/OR STENT DISLOCATION. WHEN READVANCING A GUIDEWIRE AFTER DEPLOYMENT OF STENT(S), AT NO TIME SHOULD A CATHETER BE ADVANCED ACROSS A GUIDEWIRE THAT MAY BE PASSING BETWEEN ONE OR MORE STENT STRUTS. A GUIDEWIRE MAY EXIT BETWEEN ONE OR MORE STENT STRUTS WHEN RECROSSING STENT(S). SUBSEQUENT ADVANCEMENT OF THE CATHETER COULD CAUSE ENTANGLEMENT BETWEEN THE CATHETER AND THE STENT(S), RESULTING IN ENTRAPMENT OF CATHETER/GUIDEWIRE, CATHETER TIP SEPARATION AND/OR STENT DISLOCATION. USE CAUTION WHEN REMOVING THE CATHETER FROM A STENTED VESSEL. INADEQUATELY APPOSED STENTS, OVERLAPPING STENTS, AND/OR SMALL STENTED VESSELS WITH DISTAL ANGULATION MAY LEAD TO ENTRAPMENT OF THE CATHETER WITH THE STENT UPON RETRACTION. WHEN RETRACTING THE CATHETER, ENSURE THAT THE SHORT RAIL DISTAL TIP IS PARALLEL TO THE GUIDEWIRE. SEPARATION OR BENDING OF THE GUIDEWIRE MAY RESULT IN KINKING OF THE GUIDEWIRE, DAMAGE TO THE CATHETER DISTAL TIP, AND/OR VESSEL INJURY. THE LOOPED GUIDEWIRE OR DAMAGED TIP MAY CATCH ON THE STENT STRUT RESULTING IN ENTRAPMENT." THE REVIEW OF THE DEVICE LABELING FOUND NO EVIDENCE OR INDICATION THAT THE CATHETER WAS USED AGAINST THE LABELING AND/OR DIRECTIONS FOR USE. THE CAUSE OF THE TIP DETACHMENT HAS BEEN DETERMINED TO BE OXIDATION OF THE CATHETER WHICH CAUSES EMBRITTLEMENT, INCREASING THE LIKELIHOOD OF TIP DETACHMENTS OF THIS NATURE. A ROOT CAUSE OF DESIGN WAS ASSIGNED.
A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A NON-TORTUOUS LESION WITHOUT CALCIFICATION LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AN INTRAVASCULAR ULTRASOUND (IVUS) IMAGING CATHETER WAS PREPPED AND INTRODUCED INTO THE PATIENT-WITHOUT INCIDENT-TO IMAGE THE PLACEMENT OF THE NEWLY DEPLOYED STENT. THE STENT WAS CONFIRMED BY IVUS TO BE FULLY DILATED. THERE WAS NO RESISTANCE DURING ADVANCING OR DURING WITHDRAWAL OF THE IVUS. AFTER THE CATHETER WAS REMOVED FROM THE PATIENT BODY, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE CATHETER'S RADIOPAQUE MARKER (APPROXIMATELY 2-3MM OF THE CATHETER'S TIP) REMAINED IN THE PATIENT. THE TIP OF THE CATHETER WAS SUCCESSFULLY RETRIEVED WITH A SNARE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED AS "STABLE WITH NO COMPLICATIONS".
A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A NON-TORTUOUS LESION WITHOUT CALCIFICATION LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AN INTRAVASCULAR ULTRASOUND (IVUS) IMAGING CATHETER WAS PREPPED AND INTRODUCED INTO THE PATIENT-WITHOUT INCIDENT-TO IMAGE THE PLACEMENT OF THE NEWLY DEPLOYED STENT. THE STENT WAS CONFIRMED BY IVUS TO BE FULLY DILATED. THERE WAS NO RESISTANCE DURING ADVANCING OR DURING WITHDRAWAL OF THE IVUS. AFTER THE CATHETER WAS REMOVED FROM THE PATIENT BODY, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE CATHETER'S RADIOPAQUE MARKER (APPROXIMATELY 2-3MM OF THE CATHETER'S TIP) REMAINED IN THE PATIENT. THE TIP OF THE CATHETER WAS SUCCESSFULLY RETRIEVED WITH A SNARE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED AS "STABLE WITH NO COMPLICATIONS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICROSS 40 MHZ CORONARY IMAGING CATHETER | CATHETER, INTRAVASCULAR, DIAGNOSTIC | DQO | BOSTON SCIENTIFIC - FREMONT | H749518050 | 0013649555 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | GW: WHISPER XS| GC: RUNWAY JL(MG) |